MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; GLUE,SURGICAL,ARTERIES

Model Number BG3515-5-US

Device Problem Use of Device Problem (1670)

Patient Problem Embolism (1829)

Event Date 05/27/2018

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to a conversation with the physician: "this is a (b)(6) male who underwent an aortic dissection repair 3 days ago.The patient has decreased pulses in his lower extremity, but no clinical symptoms.An angiogram shows a large, several cm mass in the distal aorta extending from the iliacs to the renal arteries.[physician] thought it might be a thrombus but could not perform an embolectomy.She said that she also could not pass a wire past the blockage.She spoke with the cardiac surgeon and they believe it could be bioglue that entered the true lumen though a re-entry point.The cardiac surgeon said he used 'a lot' of bioglue because it kept 'disappearing' into the false lumen.[manufacturer's medical director] advised [the physician] that re-entry of bioglue into the false lumen has been reported and that the instructions for use state that a balloon catheter should be used to define the distal limit for bioglue application into the false lumen.Entry of bioglue into the true lumen and circulation could lead to embolization.[manufacturer's medical director] did not provide any specific advise for treatment, but [he] did remind her that the presence of bioglue in the lumen of the aorta did carry a risk for embolization.She asked about placing an endovascular stent over the bioglue.[manufacturer's medical director] advised that we have no data regarding the safety or effectiveness of performing such a procedure.Currently the patient is asymptomatic and she will continue the patient on heparin.At this point she is uncertain how to proceed.[manufacturer's medical director] asked that she call and inform us of any additional developments with this patient.".

Event Description

According to a conversation with the physician: "this is a 78 year old male who underwent an aortic dissection repair 3 days ago.The patient has decreased pulses in his lower extremity, but no clinical symptoms.An angiogram shows a large, several cm mass in the distal aorta extending from the iliacs to the renal arteries.[physician] thought it might be a thrombus but could not perform an embolectomy.She said that she also could not pass a wire past the blockage.She spoke with the cardiac surgeon and they believe it could be bioglue that entered the true lumen though a re-entry point.The cardiac surgeon said he used 'a lot' of bioglue because it kept 'disappearing' into the false lumen.[manufacturer's medical director] advised [the physician] that re-entry of bioglue into the false lumen has been reported and that the instructions for use state that a balloon catheter should be used to define the distal limit for bioglue application into the false lumen.Entry of bioglue into the true lumen and circulation could lead to embolization.[manufacturer's medical director] did not provide any specific advise for treatment, but [he] did remind her that the presence of bioglue in the lumen of the aorta did carry a risk for embolization.She asked about placing an endovascular stent over the bioglue. [manufacturer's medical director] advised that we have no data regarding the safety or effectiveness of performing such a procedure.Currently the patient is asymptomatic and she will continue the patient on heparin.At this point she is uncertain how to proceed. [manufacturer's medical director] asked that she call and inform us of any additional developments with this patient.".

Manufacturer Narrative

A review was held of the available information.All incoming, in-process, and final inspections were completed.All inspections were within specification limits.No deviations were noted at incoming, in-process, or the final stages during the processing of the product.There was not a high scrap rate at any point during the processing of the product.No change orders were put in place during production of the product.Though correspondence with the complainant it was relayed that the cardiac surgeon associated with the usage of this product used "a lot" od product because it kept "disappearing" into the false lumen.The surgeon was advised that re-entry of the product into the false lumen has been reported and that the instructions for use state that a balloon catheter should be used to define the distal limit for the products application into the false lumen.Entry of the product into the true lumen and circulation could lead to embolization reported.A definitive root cause is unknown; however, evidence suggests that end user error contributed to the reported event.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 7637567
• MDR Text Key: 112310604
• Report Number: 1063481-2018-00021
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BG3515-5-US
• Device Catalogue Number: BG3515-5-US
• Device Lot Number: 17EUV002
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/30/2018
• Date Manufacturer Received: 05/30/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 78 YR